FDA principal deputy commissioner Lloyd Schiller says the agency is looking at changes to the Dietary Supplement Health and Education Act to enable it...
FDA places a Solid Biosciences Phase 1/2 trial of its SGT-001 Duchenne muscular dystrophy drug on clinical hold.
FDA grants F2G Ltd. a breakthrough therapy designation for olorofim for treating invasive mold infections in patients with limited or no treatment opt...
FDA issues Lipocine a complete response letter on its NDA for Tlando, an oral testosterone product candidate for testosterone replacement therapy in a...
Federal Register notice: FDA submits to OMB an information collection extension for Format and Content Requirements for Over-the-Counter Drug Product ...
Start-up pharmacy Valisure makes a name for itself by chemically validating drugs it purchases from wholesalers before fulfilling prescriptions for co...
Regenxbio files a lawsuit in DC federal court against FDA, challenging a clinical hold on its gene therapy for retinal diseases.
FDA grants AI Medical Service a Breakthrough Device Designation for its artificial intelligence programs that analyze endoscopy images for diagnosing ...